The REMODEL-CD Trial Overview
Our team is enrolling children ages 6 to 17 and young adults ages 18 to 22 years old who are newly diagnosed with moderate to severe Crohn’s disease and who will be starting infliximab (Remicade®).
About Crohn’s Disease and Infliximab Treatment
Crohn’s disease is a chronic illness that results in intestinal inflammation and unwanted gastrointestinal symptoms.
Poorly-controlled gut inflammation can lead to serious complications such as surgery, hospitalizations, growth delays and poor quality of life.
There are limited treatment options approved for use in children and adults with Crohn’s disease.
Infliximab (an infusion medication) is approved by the Food and Drug Administration (FDA) for children 6 years and up with moderate to severe Crohn’s disease.
Infliximab is safe and effective in most patients. However, some fail to respond (primary non-response) and others will lose response over time (secondary loss of response).
What Are We Testing?
Our team has developed a new method to individualize (personalize) infliximab dosing.
We will test this new method of dosing infliximab vs. the standard dosing and determine the best way to improve intestinal healing and achieve remission in patients with Crohn’s disease.
Who is Conducting the Trial?
Our team includes experts that care for children, adolescents and young adults with Crohn’s disease at 10 centers across the United States.
The National Institutes of Health (NIH) is providing the funds for this study.
Janssen Scientific Affairs, LLC will provide all study participants with infliximab (Remicade®) at no cost for up to one year.